Catalog Number 21-7302-24 |
Device Problem
Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/01/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the product was postponed due to the possibility of a cassette disconnection alarm.The event occurred upon opening the package/carton.There was no patient involvement and no patient harm.
|
|
Manufacturer Narrative
|
B3: event date unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
|
|
Manufacturer Narrative
|
One sample was received in unused condition.Visual and functional testing found no discrepancies.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
|
|
Search Alerts/Recalls
|